MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5531G416

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Bone Fracture(s) (1870); Unspecified Infection (1930); Damage to Ligament(s) (1952); Impaired Healing (2378)

Event Date 11/04/2014

Event Type  Injury  

Manufacturer Narrative

The following other devices were also listed in this report: antibiotic simplex p bone cement; cat# unknown; lot# unknown, triathlon universal tibial baseplate; cat# unknown; lot# unknown, triathlon tibial augment half block; cat# unknown; lot# unknown, triathlon offset adapter; cat# unknown; lot# unknown, triathlon fluted stem; cat# unknown; lot# unknown, it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time.The device is not available due to the ongoing litigation.Should device or additional information become available, the evaluation summary will be submitted in a supplemental report.Not returned to the manufacturer.

Event Description

It is alleged that on (b)(6) 2014, the patient was returned to the or for " surgical repair of the patellar tendon, irrigation and debridement and ordered cultures with a postop diagnosis "early postoperative infection/wound drainage with failure to heal skin margins with rupture of extensor mechanism/patellar tendon.".

Event Description

It is alleged that on (b)(6) 2014, the patient was returned to the or for " surgical repair of the patellar tendon, irrigation and debridement and ordered cultures with a postop diagnosis "early postoperative infection/wound drainage with failure to heal skin margins with rupture of extensor mechanism/patellar tendon.".

Manufacturer Narrative

Updated device information reported previously as unknown in the initial emdr associated with this pi.Simplex p with tobramycin 1 pack; cat# 6197-9-001; lot# mcv022.Tri ts baseplate size 4; cat# 5521-b-400; lot# ktzpd.Tri rm/ll tib aug sz4 10mm; cat# 5546-a-402; lot# mc7c08.Triathlon total knee system offset adapter 2mm; cat# 5570-s-020; lot# m9l44d.Tri press-fit stem 12x150mm; cat# 5566-s-012; lot# m9c49j.An event regarding surgical repair of the periprosthetic fracture, patellar tendon rupture, irrigation and debridement (infection) involving a triathlon insert was reported.The event was confirmed.Method & results: -device evaluation and results: visual, dimensional, and functional inspection were not performed as the item was not returned.-medical records received and evaluation: ¿no x-rays available for review.There is no examination of the explanted components, which were apparently intact and removed for subsiding into the host tibia, which was likely osteoporotic in this obese woman with multiple medical conditions contributing to osteoporosis.The presence of osteoporosis was further suggested by the development of an intraoperative femoral fracture while preparing the femur at the primary surgery.In retrospect it would have been prudent to use a stemmed tibial component at the primary surgery due to the patient's obesity and bone stock.As a result of revision surgery seventeen days post-op the risk of infection was heightened and, in fact, occurred.Attempts to address the infection with less than a two-stage approach resulted in persistent sepsis and patellar tendon rupture.The unfortunate clinical course of subsidence of the primary tibial component and subsequent infection was not related to factors of faulty component design, manufacturing or materials of either the primary or revision total knee components.¿ -device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there has been 1 other event for the lot referenced and 1 other event for the sterile lot.Conclusions: the event was confirmed based on the clinician¿s review, ¿in retrospect it would have been prudent to use a stemmed tibial component at the primary surgery due to the patient's obesity and bone stock.As a result of revision surgery seventeen days post-op the risk of infection was heightened and, in fact, occurred.Attempts to address the infection with less than a two-stage approach resulted in persistent sepsis and patellar tendon rupture.The unfortunate clinical course of subsidence of the primary tibial component and subsequent infection was not related to factors of faulty component design, manufacturing or materials of either the primary or revision total knee components.¿ the internal investigation of sterilization process and records confirmed the product met sal 10-6 per corresponding iso standards.

• Brand Name: X3 TRIATHLON CS INS SIZE4 16MM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 5293606
• MDR Text Key: 33404315
• Report Number: 0002249697-2015-04230
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2019
• Device Catalogue Number: 5531G416
• Device Lot Number: LDX564
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 109